Silicone Particles in Capsules Around Breast Implants: An Investigation Into Currently Available Implants in North America

Abstract

Background Breast implants have always been composed of a silicone elastomer envelope filled with either silicone gel or saline. Breast Implant Illness (BII) is a set of symptoms which has previously been linked to the leakage of silicone particles from the implants into the body. Objectives Our research aimed to quantify the number of silicone particles present in the capsules of breast implants available in North American. Methods Thirty-five peri-prosthetic capsules were sampled and analyzed, and silicone particles were counted and measured. The capsule surface area was then measured and used to calculate particle density and total number of silicone particles. Results Eighty-five percent of capsules analyzed from silicone gel implants contained silicone, with an average of 62 particles per mm3 of capsular tissue. These patients had approximately 1 million silicone particles per capsule. In contrast, none of the saline implant capsules contained silicone. Capsules from macro-textured tissue expanders contained fewer and larger silicone particles. Conclusions Silicone gel implants presented silicone particle bleeding into the peri-prosthetic capsule, totaling on average 1 million silicone particles per capsule. On the other hand, no silicone particle bleeding was observed with saline breast implants. This data suggests that particle bleeding comes from the inner silicone gel, and not from the smooth outer silicone shell. Previous studies have demonstrated the presence of breast-implant illness (BII) in patients with both silicone and saline filled implants. Therefore, our data suggests that silicone migration alone does not seem to be the sole cause of BII.